Oral product

ABSTRACT

An oral product includes a body that is wholly receivable in an oral cavity. The body includes a mouth-stable polymer matrix, cellulosic fibers embedded in the mouth-stable polymer matrix, and nicotine or a derivative thereof dispersed in the mouth-stable polymer matrix. The oral product is adapted to release the nicotine or derivative thereof from the body when the body is received within the oral cavity and exposed to saliva.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/744,930, filed Jan. 18, 2013, which claims priority to U.S.Provisional Application Ser. No. 61/588,873 filed Jan. 20, 2012 and U.S.Provisional Application Ser. No. 61/720,852 filed Oct. 31, 2012. Thedisclosures of the prior applications are incorporated by reference intheir entirety.

TECHNICAL FIELD

This document relates to oral products including mouth-stable polymersand one or more additives.

BACKGROUND

Tobacco can be enjoyed by adult tobacco consumers in a variety of forms.Smoking tobacco is combusted and the aerosol either tasted or inhaled(e.g., in a cigarette, cigar, or pipe). Smokeless tobacco products arenot combusted and include: chewing tobacco, moist smokeless tobacco,snus, and dry snuff. Chewing tobacco is coarsely divided tobacco leafthat is typically packaged in a large pouch-like package and used in aplug or twist. Moist smokeless tobacco is a moist, more finely dividedtobacco that is provided in loose form or in pouch form and is typicallypackaged in round cans and used as a pinch or in a pouch placed betweenan adult tobacco consumer's cheek and gum. Snus is a heat treatedsmokeless tobacco. Dry snuff is finely ground tobacco that is placed inthe mouth or used nasally.

A growing number of governments are now implementing restrictions onsmoking in public places, such as restaurants and transport facilities.In some countries, such as the United States, some workplaces are alsocovered by public restrictions. Smokeless products may also be banned bycertain governments or workplaces.

Trans-buccal systems such as nicotine-containing chewing gum as well astransdermal nicotine delivery systems are well known in the art. Thesesystems, however, do not consistently provide a suitable tobacco-likeexperience for some adult tobacco consumers.

SUMMARY

This specification describes an oral product that provides a satisfyingtactile and/or flavor experience. In particular embodiments, the oralproduct can provide an extended additive release time. The oral productincludes a body that is at least partially receivable in an oral cavityof an adult consumer. In some embodiments, the body includes amouth-stable polymer matrix, cellulosic fibers embedded in the stablepolymer matrix, and one or more additives dispersed in the body suchthat it is released when the body is received within the oral cavity andexposed to saliva.

The oral product, according to certain embodiments, includes nicotine ora derivative thereof. The oral product can provide a tobacco-like flavorexperience and favorable tactile experience. Combinations of additives(e.g., sweeteners, flavorants, and nicotine) can be combined to providea favorable tactile and flavor experience.

These and other embodiments can each optionally include one or more ofthe following features. In some embodiments, the oral product's bodyincludes at least 10 weight percent of the mouth-stable polymer. Themouth-stable polymer matrix can include polyurethane, silicone polymer,polyester, polyacrylate, polyethylene,poly(styrene-ethylene-butylene-styrene) (“SEBS”),poly(styrene-butadiene-styrene) (“SBS”),poly(styrene-isoprene-styrene)(“SIS”), and other similar thermoplasticelastomers, or any copolymer, mixture, or combination thereof. The oralproduct can also include a plasticizer dispersed in the mouth-stablepolymer matrix. For example, the plasticizer can be propylene glycol,glycerin, vegetable oil, triglycerides, or a combination thereof. Theoral product can also include a sweetener dispersed in the body. Thesweetener can be saccharine, sucralose, aspartame, acesulfame potassium,or a combination thereof.

The oral product, according to certain embodiments, is substantiallyfree of tobacco plant tissue. Nicotine added to the oral product can beeither synthetic or derived from tobacco. In some embodiments, the oralproduct includes between 0.1 mg and 6 mg nicotine. The oral products canalso include an additive selected from the group consisting of minerals,vitamins, dietary supplements, nutraceuticals, energizing agents,soothing agents, amino acids, chemsthetic agents, antioxidants,botanicals, teeth whitening agents, therapeutic agents, or a combinationthereof. The nicotine and/or other additives can be absorbed into thecellulosic fibers and polymer matrix.

The oral product's body can have at least 10 weight percent cellulosicfibers. The cellulosic fibers can be derived from plant tissue. In someembodiments, the cellulosic fibers includes cellulose. The cellulosicfibers can further include lignin and/or lipids. The cellulosic fiberscan be non-tobacco cellulosic fibers. For example, the cellulosic fiberscan be selected from the following: sugar beet fiber, wood pulp fiber,cotton fiber, bran fiber, citrus pulp fiber, grass fiber, willow fiber,poplar fiber, and combinations thereof. The cellulosic fibers may alsobe chemically treated prior to use. For example, the cellulosic fiberscan be CMC, HPMC, HPC, or other treated cellulosic material.

The oral product can include flavorants. The flavorants can be naturalor artificial. Flavorants can be selected from the following: licorice,wintergreen, cherry and berry type flavorants, Drambuie, bourbon,scotch, whiskey, spearmint, peppermint, lavender, cinnamon, cardamon,apium graveolents, clove, cascarilla, nutmeg, sandalwood, bergamot,geranium, honey essence, rose oil, vanilla, lemon oil, orange oil,Japanese mint, cassia, caraway, cognac, jasmin, chamomile, menthol,ylang ylang, sage, fennel, pimenta, ginger, anise, coriander, coffee,mint oils from a species of the genus Mentha, cocoa, and combinationsthereof. Synthetic flavorants can also be used. In certain embodiments,a combination of flavorants can be combined to imitate a tobacco flavor.The particular combination of flavorants can be selected from theflavorants that are generally recognized as safe (“GRAS”). Flavorantscan also be included in the oral product as encapsulated flavorants.

The body of the oral product can have a variety of different shapes,some of which include disk, shield, rectangle, and square. According tocertain embodiments, the body can have a length or width of between 5 mmand 25 mm and a thickness of between 1 mm and 10 mm.

The oral product's body can be compressible and springy. In someembodiments, the body has a compressibility @ 250 N of less than 95%,less than 90%, less than 85%, or less than 80%. In some embodiments, thebody has a compressibility of @ 250 N of between 45% and 90%. The oralproduct's body can have a compressibility @ 425 N of less than 99%. Forexample, the body can have a compressibility @ 425 N of between 60% and98%. The body can also have a percentage of springiness of at least 20%,at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, orat least 75%. For example, the body can have a percentage of springinessof between 75% and 90%.

The oral product can also include an antioxidant. In some embodiments,the oral product includes between 0.01 weight percent and 5.0 weightpercent antioxidant. Suitable antioxidants include ascorbyl palmitate,BHT, ascorbic acid, sodium ascorbate, monosterol citrate, tocopherols,propyl gallate, tertiary butylhydroquinone (TBHQ), butylatedhydroxyanisole (BHA), Vitamin E, and derivatives thereof. Thecombination of antioxidant and nicotine can reduce the formation ofnicotine-N-oxide.

The oral product can include a combination of soluble fibers andinsoluble cellulosic fibers. In some embodiments, a ratio of solublefiber to cellulosic fibers can be between 1:60 and 60:1. In someembodiments, the soluble fibers can include maltodextrin. In someembodiments, the soluble fibers comprise starch. The soluble fibers canbe derived from corn. In general, another aspect of the subject matterdescribed in this specification is methods of making and using the oralproduct. The methods of making the oral product can include the actionsof extruding a mouth-stable polymer having cellulosic fibers and/or oneor more additives dispersed therein.

The details of one or more embodiments of the subject matter describedin this specification are set forth in the accompanying drawings and thedescription below. Other features, aspects, and advantages of thesubject matter will become apparent from the description, the drawings,and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a pair of oral products.

FIGS. 2A-2O illustrate various exemplary shapes of oral products.

FIG. 3A-3J illustrate oral products having various rod, stick, or tubeconfigurations.

FIGS. 4A-4C are magnified pictures of cross-sections of an oral product.

FIG. 5A illustrates a process diagram for making oral products accordingto some embodiments.

FIG. 5B illustrates an extruder configuration for making oral productsaccording to some embodiments.

FIG. 6A illustrates a process diagram for making oral products accordingto other embodiments.

FIG. 6B illustrates an extruder configuration for making oral productsaccording to certain embodiments

FIG. 7 illustrates a rod of mouth-stable polymer exiting an extruderdie.

FIG. 8 illustrates how a cut piece of mouth-stable polymer includingfibers and/or additives can pillow.

FIGS. 9A and 9B depict compression and springiness test results.

FIG. 9C depicts some of the samples tested.

FIGS. 10A and 10B depict cumulative release timelines for menthol andnicotine from oral products.

DETAILED DESCRIPTION

The oral products described herein include a mouth-stable polymer matrixand one or more additives. The one or more additives can be dispersed inthe mouth-stable polymer matrix such that the one or more additives arereleased from the oral product when the oral product is received withinthe oral cavity and exposed to saliva. The oral products describedherein can provide a favorable additive release profile and tactileexperience.

Suitable mouth-stable polymers include thermoplastic elastomers such aspolyurethane. As used here, the term “mouth stable” means that thepolymer does not appreciably dissolve or disintegrate when exposed tosaliva within an oral cavity and at the normal human body temperature(e.g., about 98.6° F.) over a period of one hour. In addition tobiostable polymers, mouth-stable polymers can include biodegradablepolymers that breakdown over periods of days, weeks, months, and/oryears, but do not appreciably break down when held in an oral cavity andexposed to saliva for a period of one hour. In some embodiments, themouth-stable polymer is stable within an oral cavity and exposed tosaliva at the normal human body temperature for a period of at least 6hours, at least 12 hours, at least 24 hours, or at least 2 days.Accordingly, the oral products described herein can remain intact whenplaced within an oral cavity during a use period. After use, themouth-stable polymer matrix can be removed from the oral cavity anddiscarded.

The mouth-stable polymer can have shape stability. In some cases, theoral product 110 can be chewed without significant and instantaneouspermanent plastic deformation. As the oral product 100 is chewed, it canbecome more pliable and additional additives can become available forrelease into the oral cavity. Some embodiments of the oral product 110can be adapted to remain non-sticky during and after use. Afterprolonged use, certain embodiments of the oral product 110 will expandand become flatter. The oral product, however, can retain the essence ofits original shape.

One or more additives are included in the oral product and adapted to bereleased from the oral product when the oral product is placed in anoral cavity. The oral product, in some embodiments, includes nicotine.The oral product can include a combination of nicotine, sweeteners, andflavorants to mimic the flavor profile and tactile experience of certaintobacco products (e.g., a pouched smokeless tobacco product).

In some embodiments, a nicotine-containing oral product can besubstantially free of tobacco plant tissue. As used herein, the term“tobacco plant tissue” refers to processed or non-processed cellulosicparts (e.g., leaves, stems) of a member of the genus Nicotiana, but doesnot include extracts of tobacco (e.g., tobacco-derived nicotine). Forexample, an oral product can include one or more organoleptic componentsextracted from raw or processed tobacco, yet be substantially free oftobacco plant tissue.

In addition to additives, sweeteners, and flavorants, the oral productcan also include fibers, fillers, plasticizers, and/or processing aids.Fibers can help provide access to the additives, sweeteners, and/orflavorants. As will be discussed below, fibers can provide channels foradditives, sweeteners, and/or flavorants to leach out of themouth-stable polymer matrix. The fiber-polymer matrix can absorb one ormore additives and provide a pathway for one or more additives to bereleased from the oral product. The fiber-polymer matrix can be porous.In some embodiments, the fiber-polymer matrix can have a plurality ofpores having a pore diameter of between 40 microns and 60 microns and aplurality of pores having a pore diameter of between 1 micron and 10microns. During use, saliva can be absorbed into the fiber-polymermatrix to release the additives, sweeteners, and/or flavorants. Theabsorbed saliva can enter the pores and/or cause the fibers to expand,which can facilitate further release of additives, sweeteners, and/orflavorants. Mechanical action (e.g., chewing) of the oral product canfacilitate the release of the additives, sweeteners, and/or flavorants.

Fillers can also be included in the mouth-stable polymer matrix to alterthe texture or pliability of the oral product. The mouth-stable polymermatrix can also include plasticizers, which can increase the softness ofthe oral product. Processing aids can also be present in the oralproduct and be used to facilitate shaping processes.

Oral Product Shapes and Packaging

FIG. 1 depicts an example of an oral product 110. The oral product 110has a disk shape. For example, the oral product 110 can have a diameterof about 12 mm and a thickness of about 2.5 mm.

Referring now to FIGS. 2A-2N, the oral product 110 can be molded intoany desired shape. For example, referring to FIGS. 2A-2L, the oralproduct 110A-L can be formed in a shape that promotes improved oralpositioning in the oral cavity, improved packaging characteristics, orboth. In some circumstances, the oral product 110A-L can be configuredto be: (A) an elliptical-shaped oral product 110A; (B) an elongatedelliptical-shaped oral product 110B; (C) semi-circular oral product110C; (D) square or rectangular-shaped oral product 110D; (E)football-shaped oral product 110E; (F) elongated rectangular-shaped oralproduct 110F; (G) boomerang-shaped oral product 110G; (H) rounded-edgerectangular-shaped oral product 110H; (I) teardrop- or comma-shaped oralproduct 110I; (J) bowtie-shaped oral product 110J; (K) peanut-shapedoral product 110K; and (L) shield-shaped oral product. Alternatively,the oral product can have different thicknesses or dimensionality, suchthat a beveled article (e.g., a wedge) is produced (see, for example,product 110M depicted in FIG. 2M) or a hemi-spherical shape is produced.In some embodiments, the oral product has a shield shape.

In addition or in the alternative to flavorants being included withinthe mouth-stable polymer matrix, flavorants can be included on anexterior of the oral product 110. For example, referring to FIG. 2N someembodiments of an oral product 110N can be equipped with flavor strips116.

Referring to FIG. 2O, particular embodiments of the oral product 110 canbe embossed or stamped with a design (e.g., a logo, an image, or thelike). For example, the oral product 110O can be embossed or stampedwith any type of design 117 including, but not limited to, a trademark,a product name, or any type of image. The design 117 can be formeddirectly into the oral product, arranged along the exterior of theproduct 110O. The design 117 can also be embossed or stamped into thoseembodiments with a dissolvable film 116 applied thereto.

In some embodiments, the oral product 110 or products 110A-O can bewrapped or coated in an edible or dissolvable film, which may be opaque,substantially transparent, or translucent. The dissolvable film canreadily dissipate when the oral product 110 is placed in an oral cavity.In some embodiments, the oral product 110 can be coated with amouth-stable material. Exemplary coating materials include Beeswax,gelatin, acetylated monoglyceride, starch (e.g., native potato starch,high amylose starch, hydroxypropylated potato starch), Zein, Shellac,ethyl cellulose, methylcellulose, hydroxypropyl methylcellulose,carboxymethyl cellulose, and combinations thereof. For example, acoating can include a combination of gelatin and methylcellulose. Insome embodiments, a coating material can include a plasticizer. In somecase, a coating can include a colorant, a flavorant, and/or a one ormore of the additives discussed above. For example, a coating caninclude nicotine to provide a user with an initial nicotine burst. Insome cases, the matrix of mouth-stable polymer 120 can have surfacesroughened to improve the adherence of a coating. In some cases, acoating can provide a glossy or semi-glossy appearance, a smoothsurface, and/or an appealing visual aesthetic (e.g., a nice color). Insome embodiments, the coating (e.g., a beeswax, Zein, acetylatedmonoglyceride, and/or hydroxypropylated potato starch coating) canprovide soft mouth feel. In some embodiments, the coating (e.g., amethylcellulose, hydroxypropyl methylcellulose, carboxymethyl cellulose,ethyl cellulose, and/or gelatin coating) can provide a hard outercoating.

One or more oral products 110 can be packaged in a variety ofconventional and non-conventional manners. For example, a plurality oforal products 110 can be packaged in a container having a lid. In otherembodiments, a plurality of oral products 110 can be stacked andpackaged in a paper, plastic, and/or aluminum foil tube. The packagingcan have a child-resistant lid.

The oral product 110 can also include additional elements. In someembodiments, a mouth-stable polymer matrix including nicotine or aderivative thereof can be attached to a rod, tube, or stick. Forexample, FIGS. 3A-3J illustrate tubes attached to a mouth-stable polymermatrix tips. FIG. 3A depicts an embodiment of an oral product having atip piece 310 and a tube piece 320. The tip piece 310 can include themouth-stable polymer matrix having fibers and/or one or more additiveswithin the polymer matrix. The tip piece 310 can be sized and shaped tobe at least partially received in an oral cavity. The tube piece 320 canbe made of any conventional polymer. During use the tube piece 320 canact as holder for the tip piece 310. The tube piece 320 and the tippiece 310 can be attached by a snap-fit attachment feature 330, as shownin FIG. 3B.

The tube piece 320 can be reusable. For example, multiple tip pieces 310can be packaged with a single tube piece 320 and a user can switch offthe tip pieces 310. In other embodiments, the tube pieces 320 can beintended for a single use. In some embodiments, the tube pieces 320 caninclude flavorants within the tube. The flavorants can be adapted to bereleased when air is drawn through the tube 320. For example, FIG. 3Cdepicts a tube including a flavor ribbon 322. FIG. 3D depicts a tube 320including a flavor strip 324 and a plurality of flavor beads 326. FIG.3E depicts a tube 320 including a compressed mass 328 of flavor beads326. In some embodiments, the inside of the tube can have structureadapted to alter the flow pattern of air drawn into the tube. Forexample, FIG. 3F depicts a tube 320F having a series of steps andconstrictions 340 adapted to alter the flow pattern of air drawn intothe tube. FIG. 3F also depicts an alternative connection feature 330F.

FIG. 3G depicts an embodiment having a recorder-like shape. As shown, atip piece 310G is connected to the contoured tube piece 320. Forexample, the recorder-shaped tip 310G can be composed of a mouth-stablepolymer matrix that includes cellulosic fibers, nicotine, one or moresweeteners, and one or more flavorants. As shown, the tip piece 310G issized and shaped to be at least partially received within an adult'soral cavity.

FIG. 3H depicts a similarly shaped oral product having a plasticrecorder-shaped tip 310H that includes a reusable plastic part 312 and amouth-stable polymer matrix part 315. FIGS. 3I and 3J depict embodimentshaving alternatively shaped tip pieces 310I and 310J. FIG. 3I depicts anembodiment having a tapered tube 320I. FIG. 3J depicts an embodimenthaving vent holes at the non-tip end of the tube piece 320J.

In some embodiments, a system or kit of different tubes and rods and/ordifferent tips can be packaged together, each having the same type ofattachment features. Embodiments having each of the combinations of tipsand tubes or rods shown in FIGS. 3A-3J are contemplated.

Oral Product Properties

The oral product 110 can provide a favorable tactile experience (e.g.,mouth feel). The oral product 110 can also retain its shape duringprocessing, shipping, handling, and optionally use. As noted above, theoral product 110 includes a mouth-stable polymer matrix that does notappreciably dissolve or disintegrate when placed in an oral cavity andexposed to saliva. In some embodiments, the oral product 110 can have anelasticity allowing an adult consumer to work the product within themouth. In some embodiments, the oral product 110 has at least some shapememory and thus can return to shape after being squeezed between teethin an oral cavity. Working of the oral product 110 within the oralcavity can accelerate the release of the additives, sweeteners, and/orflavorants within the mouth-stable polymer matrix.

During use, the oral product 110 can absorb saliva into thepolymer-fiber matrix. The saliva can cause the polymer-fiber matrix toswell, which can further increase access to different sections of thepolymer-fiber matrix. Physical activity, such as chewing of the productin the mouth, can also accelerate the polymer-matrix swelling andtherefore the release of additives. As the product is chewed, saliva canaccess different sections of the polymer-fiber matrix. The mouth-stablepolymer can have shape stability. In some cases, the oral product 110can be chewed without significant and instantaneous permanent plasticdeformation (such as that experienced by a chewing gum when chewed). Asthe oral product 100 is chewed, it can become more pliable andadditional additives can become available for release into the oralcavity. Some embodiments of the oral product 110 can be adapted toremain non-sticky during and after use. After prolonged use, certainembodiments of the oral product 110 will expand and become flatter. Theoral product, however, can retain the essence of its original shape. Theamount of deformation will depend on the duration of use and an amountof mouth force used. As the product is used, it can increase in bothweight and volume, due to the swelling. Simulated chewing tests usingartificial saliva show a weight increases ranging from 4% to 75%depending on the selection of experimental parameters. With greater thephysical manipulation, the oral product 110 will have a greater amountof swelling and thus have a larger weight gain. In certain embodiments,the oral product 110 will have an increase in weight of between 4 and 75percent when chewed by an adult consumer for 30 minutes.

One way of characterizing the properties of the oral product is bymeasuring the compressibility and springiness of the product. Thecompressibility can be calculated as a percentage of reduction inthickness of the sample when the sample is compressed with astandardized probe with a particular force. As used herein, the term“compression @ 250 N test” defines a test of a sample where the sampleis placed on a flat stationary surface and twice compressed with a 10mm-diameter-sphere-tipped probe with a force of 250 N with a hold timeof 30 seconds between compressions. The “percentage of compression @ 250N” is the maximum amount of reduction in thickness of the sample duringthe compression @250 N test. For example, if a 3 mm thick sample iscompressed to a minimum thickness of 1.5 mm during either of the twocompressions, the sample is said to have a 50% compression @ 250 N. Asused herein, the term “compression @ 425 N test” defines a test of asample where the sample is placed on a flat stationary surface and twicecompressed with a 10 mm-diameter-sphere-tipped probe with a force of 425N with a hold time of 30 seconds between compressions. For comparison, anormal human bite force is typically between 400 and 500 N.

In some embodiments, the oral product 110 has a percentage ofcompression @ 250 N of less than 95%. In certain embodiments, the oralproduct 110 has a percentage of compression @ 250 N of less than 90%,less than 85%, or less than 80%. In certain embodiments, the oralproduct 110 has a percentage of compression @ 250 N of at least 10%, atleast 25%, or at least 40%. For example, the oral product can have apercentage of compression @ 250 N of between 45% and 80%. In someembodiments, the oral product 110 has a percentage of compression @ 425N of less than 99%. In certain embodiments, the oral product 110 has apercentage of compression @ 425 N of less than 98%, less than 97%, orless than 96%. In certain embodiments, the oral product 110 has apercentage of compression @ 425 N of at least 10%, at least 25%, atleast 50%, or at least 60%. For example, the oral product can have apercentage of compression @ 425 N of between 65% and 98%. FIG. 9A,discussed in more detail below, depicts examples of compression testresults for certain embodiments of oral products, for gum (both chewedand fresh), and for an eraser.

The springiness of a sample can be measured by measuring the percentageof recovery after a sample is compressed. As used herein, the term“percentage of springiness” means the percentage of thickness recoveryof the sample during a 30 second recovery time after being compressed bythe compression @ 425 N test using the 10 mm-diameter-sphere-tippedprobe. For example, if a sample is compressed from an original thicknessof 3.0 mm to a thickness of 2.0 mm and then recovers to 2.5 mm after 30seconds, the springiness of the sample would be 50%. In someembodiments, the oral product 110 has a percentage of springiness of atleast 20%. In certain embodiments, the oral product 110 has a percentageof springiness of at least 40%, at least 50%, at least 60%, at least70%, at least 75%, or at least 80%. In certain embodiments, thepercentage of springiness is less than 95%, less than 90%, or less than87%. For example, the oral product can have a percentage of springinessof between 75% and 90%. FIG. 9B, discussed in more detail below, depictsexamples of springiness test results for certain embodiments of oralproducts, for gum (both chewed and fresh), and for an eraser.

The particular materials used in the oral product 110 and the processingtechniques discussed below can have an impact on the compressibility andspringiness of the oral product. In addition to different materials havedifferent compressibility and springiness properties, the incorporationof air bubbles or channels, or different fillers and/or fibers can alsohave an impact on the elasticity and pliability of the oral product.Additionally, the material properties of the overall oral product 110can change as additives are released. In some embodiments, fibers and/orfillers can also dissolve or disintegrate during use and thus alter thematerial properties of the oral product 110 during use.

The oral product 110 can have a variety of colors. In some embodiments,the oral product 110 has an off-white color. In other embodiments,natural and artificial coloring can be added to the mouth-stable polymerbefore or during the molding process to form oral products 110 having apredetermined color. Encapsulated flavors can be added during theextrusion process to create speckles, patterns or dots within the oralproduct.

Polymers

The mouth-stable polymer can be a variety of different biocompatible andbiostable polymers. In some embodiments, the mouth-stable polymer is apolymer generally recognized as safe by an appropriate regulatoryagency. In some embodiments, the polymer is a thermoplastic polymer. Thepolymer can also be a thermoplastic elastomer. For example, suitablemouth-stable polymers include polyurethanes, silicon˜ polymers,polyesters, polyacrylates, polyethylenes, polypropylenes,polyetheramides, polystyrenes (e.g., acrylonitrile butadiene styrene,high impact polystyrenes (HIPS)) polyvinyl alcohols, polyvinyl acetates,polyvinyl chlorides, polybutyl acetates, butyl rubbers (e.g.,polyisobutylenes), SEBS, SBS, SIS, and mixtures and copolymers thereof.In certain embodiments, the mouth-stable polymer is foodgrade ormedical-grade polymers (e.g., medical-grade polyurethane).

The mouth-stable polymer forms the mouth-stable polymer matrix of theoral product 110. In some embodiments, the oral product includes atleast 10 weight percent of one or more mouth-stable polymers. In certainembodiments, the oral product includes at least 20 weight percent, atleast 30 weight percent, at least 40 weight percent, at least 50 weightpercent, at least 60 weight percent, at least 70 weight percent, atleast 80 weight percent, or at least 90 weight percent of one or moremouth-stable polymers. In certain embodiments, the oral product includesbetween 10 and 90 weight percent of one or more mouth-stable polymers.Accordingly to some embodiments, the oral product includes between 40and 80 weight percent of the mouth-stable polymers. Some embodiments ofthe oral product have between 55 and 70 weight percent polymers.

The mouth-stable polymer according to certain embodiments has a flexuralmodulus of at least 5 MPa when tested according to ASTM Testing MethodD790 or ISO 178 at 23 degrees Celsius. In some embodiments, the flexuralmodulus is at least 10 MPa. For example, the flexural modulus can bebetween 10 MPa and 30 MPa. In some embodiments, the mouth-stable polymeris a grade that complies with food-contact regulations applicable in oneor more countries (e.g., US FDA regulations). In some embodiments, themouth-stable polymer can be a polyurethane, SIS, or other thermalplastic elastomer meeting the requirements of the FDA-modified ISO10993, Part 1 “Biological Evaluation of Medical Devices” tests withhuman tissue contact time of 30 days or less. The mouth-stable polymercan have a shore Hardness of 50 D or softer, a melt flow index of 3 g/10min at 200° C./10 kg, a tensile strength of 10 MPa or more (using ISO37), and a ultimate elongation of less than 100% (using ISO 37).

Additives

A variety of additives can be included in the oral product 110. Theadditives can include alkaloids (e.g., nicotine), minerals, vitamins,dietary supplements, nutraceuticals, energizing agents, soothing agents,coloring agents, amino acids, chemsthetic agent, antioxidants, foodgrade emulsifiers, pH modifiers, botanicals (e.g., green tea), teethwhitening (e.g., SHRIMP), therapeutic agents, sweeteners, flavorants,and combinations thereof. In certain embodiments, the additives includenicotine, sweeteners, and flavorants. With certain combinations ofnicotine, sweeteners, and flavorants, the oral product may provide aflavor profile and tactile experience similar to certain tobaccoproducts.

Nicotine

Nicotine within the oral product can be tobacco-derived nicotine,synthetic nicotine, or a combination thereof. In certain embodiments,the oral product includes between 0.1 mg and 6.0 mg of nicotine. In someof these embodiments, the oral product includes between 1.0 mg and 3.0mg of nicotine.

Tobacco-derived nicotine can include one or more other tobaccoorganoleptic components other than nicotine. The tobacco-derivednicotine can be extracted from raw (e.g., green leaf) tobacco and/orprocessed tobacco. Processed tobaccos can include fermented andunfermented tobaccos, dark air-cured, dark fire cured, burley, fluecured, and cigar filler or wrapper, as well as the products from thewhole leaf stemming operation. The tobacco can also be conditioned byheating, sweating and/or pasteurizing steps as described in U.S.Publication Nos. 2004/0118422 or 2005/0178398. Fermenting typically ischaracterized by high initial moisture content, heat generation, and a10 to 20% loss of dry weight. See, e.g., U.S. Pat. Nos. 4,528,993;4,660,577; 4,848,373; and 5,372,149. By processing the tobacco prior toextracting nicotine and other organoleptic components, thetobacco-derived nicotine may include ingredients that provide afavorable experience.

The tobacco-derived nicotine can be obtained by mixing cured andfermented tobacco with water or another solvent (e.g., ethanol) followedby removing the insoluble tobacco material. The tobacco extract may befurther concentrated or purified. In some embodiments, select tobaccoconstituents can be removed. Nicotine can also be extracted from tobaccoin the methods described in the following U.S. Pat. Nos. 2,162,738;3,139,436; 3,396,735; 4,153,063; 4,448,208; and 5,487,792.

The nicotine can also be purchased from commercial sources, whethertobacco-derived or synthetic. In other embodiments, the oral product caninclude a derivative of nicotine (e.g., a salt of nicotine).

Antioxidants

The oral product 110 can also include one or more antioxidants. In someembodiments, an oral product 110 can include a combination of nicotineand antioxidants. Antioxidants can result in a significant reduction inthe conversion of nicotine into nicotine-N-oxide when compared to oralproducts without antioxidants. In some cases, an oral product caninclude 0.01 and 5.00 weight percent antioxidant, between 0.05 and 1.0weight percent antioxidant, between 0.10 and 0.75 weigh percentantioxidant, or between 0.15 and 0.5 weight percent antioxidant.Suitable examples of antioxidants include ascorbyl palmitate (a vitaminC ester), BHT, ascorbic acid (Vitamin C), and sodium ascorbate (VitaminC salt). In some embodiments, monosterol citrate, tocopherols, propylgallate, tertiary butylhydroquinone (TBHQ), butylated hydroxyanisole(BHA), Vitamin E, or a derivative thereof can be used as theantioxidant. For example, ascorbyl palmitate can be the antioxidant inthe formulations listed in Table I. Antioxidants can be incorporatedinto the polymer (e.g., polyurethane) during an extrusion process orafter the polymer is extruded (e.g., during a post-extrusion flavoringprocess).

Table I (below) compares a test sample with a control sample to comparehow the inclusion of antioxidant in an oral product 110 impacts theabout of nicotine-N-oxide formed in the oral product after aging for 2weeks and 4 weeks. The ambient samples were held at 25° C. and 65%relative humidity. Both the control and test samples included 1.5 mg ofnicotine per piece. As shown, the inclusion of antioxidant significantlyreduces the amount of nicotine-N-oxide formed in the oral product 110.

TABLE I Nicotine N Oxide % Difference between Control* Test** Test andControl Week 0 0.023% 0.035% — Ambient Week 2 0.510% 0.156% −69.49%Ambient Week 4 0.735% 0.261% −64.51% Ambient Week 6 0.893% 0.277%−69.04% Ambient Week 8 0.950% 0.449% −52.68% Ambient Week 10 0.890%0.491% −44.87% Ambient Week 12 1.009% 0.539% −46.64% *The control isfree of antioxidant, but includes 1.5 mg nicotine. **The test includesabout 0.15% ascorbyl palmitate antioxidant and about 1.5 mg nicotine.

In some cases, the oral product 110 can have a conversion of less than0.50% of nicotine into nicotine-N-oxide after aging the oral product 110for 2 weeks at 25° C. and 65% relative humidity. In some cases, the oralproduct 110 can have a conversion of less than 0.20% of nicotine intonicotine-N-oxide after aging the oral product 110 for 2 weeks at 25° C.and 65% relative humidity. In some cases, the oral product 110 can havea conversion of less than 0.70% of nicotine into nicotine-N-oxide afteraging the oral product 110 for 4 weeks at 25° C. and 65% relativehumidity. In some cases, the oral product 110 can have a conversion ofless than 0.30% of nicotine into nicotine-N-oxide after aging the oralproduct 110 for 4 weeks at 25° C. and 65% relative humidity. In somecases, the oral product 110 can have a conversion of less than 0.80% ofnicotine into nicotine-N-oxide after aging the oral product 110 for 6weeks at 25° C. and 65% relative humidity. In some cases, the oralproduct 110 can have a conversion of less than 0.40% of nicotine intonicotine-N-oxide after aging the oral product 110 for 6 weeks at 25° C.and 65% relative humidity. In some cases, the oral product 110 can havea conversion of less than 0.30% of nicotine into nicotine-N-oxide afteraging the oral product 110 for 6 weeks at 25° C. and 65% relativehumidity. In some cases, the oral product 110 can have a conversion ofless than 0.85% of nicotine into nicotine-N-oxide after aging the oralproduct 110 for 8 weeks at 25° C. and 65% relative humidity. In somecases, the oral product 110 can have a conversion of less than 0.50% ofnicotine into nicotine-N-oxide after aging the oral product 110 for 8weeks at 25° C. and 65% relative humidity. In some cases, the oralproduct 110 can have a conversion of less than 0.85% of nicotine intonicotine-N-oxide after aging the oral product 110 for 10 weeks at 25° C.and 65% relative humidity. In some cases, the oral product 110 can havea conversion of less than 0.55% of nicotine into nicotine-N-oxide afteraging the oral product 110 for 10 weeks at 25° C. and 65% relativehumidity. In some cases, the oral product 110 can have a conversion ofless than 0.95% of nicotine into nicotine-N-oxide after aging the oralproduct 110 for 12 weeks at 25° C. and 65% relative humidity. In somecases, the oral product 110 can have a conversion of less than 0.60% ofnicotine into nicotine-N-oxide after aging the oral product 110 for 12weeks at 25° C. and 65% relative humidity.

The presence of antioxidant can also reduce the formation of othertobacco derived impurities, such as Cotinine and myosime, as shown inTable II (below). Antioxidant level 1 is 0.075% in the formula and level2 is 0.15% in the formula. The control sample includes no antioxidant.The antioxidant is ascorbyl palmitate.

TABLE II Week 4 % Relative to Nicotine Concentration (Average, n = 3)Storage Conditions Packaging Type Myosmine Nornicotine AnabasineCotinine Anatabine Nicotine-Oxide b-Nicotyrine Total Ambient (25°Control 0.125% 0.014% ND 0.023% ND 0.735% 0.017% 0.913% C., 60 RH) AOLevel 1 0.041% 0.018% ND 0.007% ND 0.188% 0.009% 0.263% AO Level 20.038% 0.029% ND 0.007% ND 0.261% 0.008% 0.343%

Sweeteners

A variety of synthetic and/or natural sweeteners can be used asadditives in the oral product 110. Suitable natural sweeteners includesugars, for example, monosaccharides, disaccharides, and/orpolysaccharide sugars, and/or mixtures of two or more sugars. Accordingto some embodiments, the oral product 110 includes one or more of thefollowing: sucrose or table sugar; honey or a mixture of low molecularweight sugars not including sucrose; glucose or grape sugar or cornsugar or dextrose; molasses; corn sweetener; corn syrup or glucosesyrup; fructose or fruit sugar; lactose or milk sugar; maltose or maltsugar or maltobiose; sorghum syrup; mannitol or manna sugar; sorbitol ord-sorbite or d-sobitol; fruit juice concentrate; and/or mixtures orblends of one or more of these ingredients. The oral product 110 canalso include non-nutritive sweeteners. Suitable non-nutritive sweetenersinclude: stevia, saccharin; Aspartame; sucralose; or acesulfamepotassium.

Flavorants

The oral product 110 can optionally include one or more flavorants. Theflavorants can be natural or artificial. For example, suitableflavorants include wintergreen, cherry and berry type flavorants,various liqueurs and liquors (such as Dramboui, bourbon, scotch, andwhiskey) spearmint, peppermint, lavender, cinnamon, cardamon, apiumgraveolents, clove, cascarilla, nutmeg, sandalwood, bergamot, geranium,honey essence, rose oil, vanilla, lemon oil, orange oil, Japanese mint,cassia, caraway, cognac, jasmin, chamomile, menthol, ylang ylang, sage,fennel, pimenta, ginger, anise, coriander, coffee, liquorish, and mintoils from a species of the genus Mentha, and encapsulated flavors. Mintoils useful in particular embodiments of the oral product 110 includespearmint and peppermint. Synthetic flavorants can also be used. Incertain embodiments, a combination of flavorants can be combined toimitate a tobacco flavor. The particular combination of flavorants canbe selected from the flavorants that are generally recognized as safe(“GRAS”) in a particular country, such as the United States. Flavorantscan also be included in the oral product as encapsulated flavorants.

In some embodiments, the flavorants in the oral product 110 are limitedto less than 20 weight percent in sum. In some embodiments, theflavorants in the oral product 110 are limited to be less than 10 weightpercent in sum. For example, certain flavorants can be included in theoral product 110 in amounts of about 1 weight percent to 5 weightpercent.

Other Additives

The oral product 110 may optionally include other additives. Forexample, these additives can include non-nicotine alkaloids, dietaryminerals, vitamins, dietary supplements, therapeutic agents, andfillers.

Oral products 110 can also include vitamins, dietary minerals, otherdietary supplements, and/or therapeutic agents. For example, suitablevitamins include vitamins A, B1, B2, B6, C, D2, D3, E, F, K, and P. Forexample, an oral product 110 can include C-vitamins with nicotine.Suitable dietary minerals include calcium (as carbonate, citrate, etc.)or magnesium (as oxide, etc.), chromium (usually as picolinate), andiron (as bis-glycinate). One or more dietary minerals could be includedin an oral product with or without the use of other additives. Otherdietary supplements and/or therapeutic agents can also be included asadditives.

The oral product 110 can also include fillers such as starch, di-calciumphosphate, lactose, sorbitol, mannitol, and microcrystalline cellulose,calcium carbonate, dicalcium phosphate, calcium sulfate, clays, silica,glass particles, sodium lauryl sulfate (SLS), glyceryl palmitostearate,sodium benzoate, sodium stearyl fumarate, talc, and stearates (e.g., Mgor K), and waxes (e.g., glycerol monostearate, propylene glycolmonostearate, and acetylated monoglycerides), stabilizers (e.g.,ascorbic acid and monosterol citrate, BHT, or BHA), disintegratingagents (e.g., starch, sodium starch glycolate, cross caramellose, crosslinked PVP), pH stabilizers, or preservatives. In some embodiments, theamount of filler in the oral product 110 is limited to less than 10weight percent in sum. In some embodiments, the amount of filler in theoral product 110 is limited to be less than 5 weight percent in sum. Insome embodiments, the fillers are mouth stable. In other embodiments,the fillers can dissolve or disintegrate during use and thus result inan oral product that becomes more pliable during use.

Fibers

The oral product can include fibers within the mouth-stable polymermatrix. As will be discussed below, the fibers can be mixed with themouth-stable polymer prior to or during an extrusion process. As shownin FIG. 4, the fibers provide passages in the mouth-stable polymermatrix, which can permit certain additives within the mouth-stablepolymer matrix to be released into an oral cavity when the oral productis received in an oral cavity and exposed to saliva. The additives canbe absorbed in fiber-polymer matrix and/or form pockets within themouth-stable polymer matrix, which can be accessed via the fibers 130.

FIGS. 4A-4C depicts cross-sections of oral products 100. FIGS. 4A and 4Bare images from a scanning electron microscope (SEM) (XL30 ESEM TMP,FEI/Philips, the Netherlands). The SEM microscope was operated at 20 kVelectron acceleration voltage and images were recorded at differentmagnifications. FIG. 4A is an SEM image showing the porous structure ofthe mouth stable polymer matrix 120. FIG. 4A highlights pores 135 ahaving diameters of between 20 and 60 microns. FIG. 4B is also an SEMimage showing the porous structure of the mouth stable polymer matrix120. FIG. 2B, however, has an increased magnification, thus pores 135 bhaving diameters of between 1 and 10 microns can be seen.

FIG. 4C is a confocal laser scanning microscopy (CLSM) image. In CLSM,only fluorescent labeled materials are visible. The product was stainedwith the fluorescent dyes of acridinorange and acriflavine,respectively. The light source was an Argon laser using λex=488 nm(acridinorange) and a HeNE laser using λex=594 nm (acriflavin). Thesignals were emitted in the wavelength interval of 500-550 nm and610-650 nm. FIG. 4C was converted into gray scale for the purposes ofthis application. The darker areas show the placement of fibers 130 inthe mouth-stable polymer matrix. The lighter grey areas show themouth-stable polymer 120 (in this case, polyurethane). The white areasin the image are pores in the structure. In some embodiments, the fibersare hydrophilic such that water-soluble additives can be wicked by thefibers. In some embodiments, the fibers can dissolve to leave channels.Additives can be present in the pores 135 of the mouth-stable polymermatrix 120.

The fibers can be cellulosic fibers. The cellulosic fibers can bederived from plant tissue. In some embodiments, the cellulosic fibersinclude cellulose. The cellulosic fibers can further include ligninand/or lipids. Suitable sources for cellulosic fibers include wood pulp,cotton, sugar beets, bran, citrus pulp fiber, switch grass and othergrasses, Salix (willow), tea, and Populus (poplar). In some embodiments,the cellulosic fibers can be chopped or shredded plant tissue comprisingvarious natural flavors, sweeteners, or active ingredients. In someembodiments, the oral product 110 can include nicotine as an additive(optionally with additional sweeteners and flavors) and non-tobaccocellulosic fiber, and thus be substantially free of tobacco planttissue.

The cellulosic fibers can have a variety of dimensions. The dimensionsof the fibers (in addition to the amount) can impact the releasecharacteristics of the additives. For example, cellulosic fibers can behydrophilic, thus water soluble additives (e.g., nicotine) canpreferentially be absorbed in fiber-polymer matrix. As will be discussedin the Examples below, the release profile of nicotine from apolyurethane oral product 110 can be impacted by both the fiber sizesand the amounts of fiber. In certain embodiments, the cellulosic fibercan be processed to have an average fiber size of less than 200micrometers. In particular embodiments, the fibers are between 75 and125 micrometers. In other embodiments, the fibers are processed to havea size of 75 micrometers or less.

The oral product 110 can also include soluble fibers. The soluble fiberscan be adapted to dissolve when exposed to saliva when the oral product110 is received in an oral cavity. In some embodiments, the solublefiber can be a maltodextrin. The maltodextrin can be derived from corn.For example, Soluble Dietary Fiber can be included in an oral product110. Soluble fibers can be used alone or with cellulosic fibers toprovide channels 135 for additives 140 and/or 142 to be released fromthe oral product 110. As the soluble fibers dissolve, the oral product110 can become more flexible and the additional channels can open up topermit the release of additional additive deposits 140 or 142. Suitablesoluble fibers include psyllium fibers. In other embodiments, the fiberscan be partially soluble. For example, sugar beet fibers can partiallydissolve during use.

In some embodiments, an oral product 110 can include a combination ofsoluble and insoluble fibers. The ratio of soluble to insoluble fibercan impact the softness of texture of the oral product 110. The ratio ofsoluble to insoluble fiber can also impact the compressibility of theoral product 110. In some embodiments, a ratio of soluble to insolublefiber is between 1:60 and 60:1. In some embodiments, the ratio ofsoluble to insoluble fiber is greater than 1:50, greater than 1:40,greater than 1:30, greater than 1:20, greater than 1:10, or greater than1:5. In some embodiments, the ratio of soluble to insoluble fiber isless than 1:1, less than 1:2, less than 1:5, less than 1:10, less than1:20, or less that 1:30. In some case, an oral product having a mixtureof soluble and insoluble fibers can have a percentage of compression @250 N of between 60 percent and 98 percent, between 65 percent and 95percent, between 70 percent and 90 percent, or between 80 and 89percent.

Table III, below, depicts the percentage of compression @ 250 N for oralproducts having different percentages of soluble and insoluble fibers.As shown, the inclusion of soluble fiber can increase thecompressibility of the oral product, which can also be perceived as asofter mouth feel by an adult tobacco consumer. The soluble and theinsoluble fiber depicted in Table I were pre-mixed and added into theprocess via a single feeder, but separate fiber feeders can also beadded. For example, larger commercial processes can include additionalfiber feeders to meter the insoluble and soluble fiber separately toproduce a desired ratio.

TABLE III Proto- Compres- Soluble Insol- Poly- type sion Fiber uble ure-Antiox- # @250N FiberSol-2 ™ Fiber thane idant Control 60% 0.0% 31.392%56.505% 0.0% Sample A 72% 1.162% 30.981% 55.765% 0.148% Sample B 83%2.351% 28.994% 56.421% 0.15% Sample C 88% 2.344% 28.907% 56.252% 0.448%Plasticizers

The oral product 110 can also include one or more plasticizers.Plasticizers can soften the final oral product and thus increase itsflexibility. Plasticizers work by embedding themselves between thechains of polymers, spacing them apart (increasing the “free volume”),and thus significantly lowering the glass transition temperature for theplastic and making it softer. Suitable plasticizers include propyleneglycol, glycerin, vegetable oil, and medium chain triglycerides. In someembodiments, the plasticizer can include phthalates. Esters ofpolycarboxylic acids with linear or branched aliphatic alcohols ofmoderate chain length can also be used as plasticizers. Moreover,plasticizers can facilitate the extrusion processes described below. Insome embodiments, the oral product 110 can include up to 20 weightpercent plasticizer. In some embodiments, the oral product 110 includesbetween 0.5 and 10 weight percent plasticizer, the oral product 110 caninclude between 1 and 8 weight percent plasticizer, or between 2 and 4weight percent plasticizer. For example, an oral product comprising apolyurethane polymer matrix and include about 3 to 6.5 weight percent ofpropylene glycol.

Molding Processes

The oral product 110 can be produced by extruding a mouth-stable polymer(e.g., polyurethane) with fibers (e.g., cellulosic fiber) and/oradditive (e.g., nicotine) to form a rod of a mouth-stable polymer matrixincluding fibers and/or additives. The rod is cut into individual oralproducts 110. FIGS. 5A and 5B depict exemplary methods to form oralproducts 110.

Referring to the extrusion process illustrated in FIG. 5A, amouth-stable polymer 510 (e.g., polyurethane) is introduced into anextruder for extrusion 520 along with fibers 512 (e.g., cellulosicfibers). The fibers 512 can be passed through a sieve 514 prior tointroduction into the extruder. A mixture of additives 516 can also beintroduced into the extruder. The mixture of additives 516 can be asolution (as shown). As shown, the additives can include a plasticizer517 (e.g., propylene glycol) and a sweetener 518 (e.g., sucralose). Themixture of additives can also be provided in slurry form or a dry mix ofpowdered additives.

FIG. 5B illustrates an example of how the mouth-stable polymer 510(e.g., polyurethane) can be compounded with fiber 512 and a mixture ofadditives 516. As shown, polyurethane pellets 510 and cellulosic fibers512 can be introduced into an infeed section of an extruder. A firstsection of the extruder melts and mixes the polymer, elevating thetemperature to about 150° C. The mixture 516 of propylene glycol 517 andsucralose 518 can be injected into the extruder downstream of the infeedsection of the extruder. The polymer/fiber/plasticizer/sweetener mixturecan then be extruded out of an extrusion die 720 at a temperature ofabout 150° C. An example of an extrusion die is shown in FIG. 7. Forexample, the extruder of FIG. 5B can operate at a mass flow rate ofabout 1.8 lbs/hour.

The polymer-fiber combination can exit an extrusion die 720 as a rod 710and onto a moving conveyor 730, as shown in FIG. 7. The size of theextrusion die 720, the take away speed of the moving conveyor 730, themixture of polymer-fiber combination, and the temperature of the mixtureexiting the die 720 can all have an impact on the final diameter of therod 710.

The extruded polymer-fiber rod 710 is then cut in a cutting process 530,as shown in FIG. 5A. The cutting can be hot-face cutting. Hot-facecutting can occur immediately after the rod 720 exits the extrusion die720. The cutting can induce pillowing of the polymer matrix, as shown inFIG. 8. The cutting process 530 can also include a process of roundingthe edges of the cut polymer-fiber composite. For example, a pelletizercan be used to round the edges. The pelletizer can also help to cool theoral products 110. In other embodiments, the extruded polymer-fiber rod710 is cooled prior to cutting.

Before or after cutting, additional additives and/or flavorants can beadded to the extruded polymer-fiber rod and/or pieces. As shown in FIG.5A, a mixture of additives 550 and a mixture of flavorants 560 can beabsorbed into polymer-fiber pieces in one or more absorbing processes540. The mixture of additives 550 can include 552 and water 554. Amixture of flavorants 560 can include a flavor 562 (e.g., wintergreen)and a carrier 564 (e.g., ethanol). The oral products 110 could then bedried, packaged, and sealed.

FIG. 6A depicts an alternative arrangement where a mouth-stable polymer510 (e.g., polyurethane) is compounded with a mixture 516 of one or moreplasticizers 517 (e.g., propylene glycol) and/or sweeteners 518 (e.g.,sucralose) in a first extrusion process 622. The compoundedpolymer/plasticizer/sweetener mixture is then compounded with fiber 512in a second extrusion process 624. As shown, additives such as nicotine552 and/or flavorants 562 can also be added during the second extrusionprocess 624. In some embodiments, the compounding in the first extrusionprocess occurs at a higher temperature than the compounding during thesecond extrusion process. Both extrusion processes can occur in a singleextruder.

FIG. 6B depicts an arrangement of an extruder where the active,plasticizer, fibers and flavorants are all added the mouth-stablepolymer in the extruder. Polyurethane pellets 510 are added to an infeedsection 610 of the extruder 620. Plasticizer 517 (e.g., propyleneglycol) (and optionally actives, sweeteners, and/or carriers) areinjected into a first section of the extruder and compounded with thepolyurethane. A vent 640 can be provided to release volatiles.Cellulosic fibers 512 can be introduced into the extruder through a sidefeeder 630. A flavorant mixture 560 can be added through liquid injector660 in a flavor mixing section of the extruder. Active 52 (e.g.,nicotine) and plasticizer 517 can also be injected through liquidinjector 660. The mixture can then be extruded through an extrusion die720 at a temperature of about 165° C. The extruded mixture can behot-cut as it exits the extrusion die 720 and passed to a pelletizer. Inother embodiments, the extruded mixture can be cooled on a coolingconveyer and cut. For example, the extruder of FIG. 6B can operate at amass flow rate of about 5.5 lbs/hour. After cutting, the oral products110 can be further flavored in a pan coater. The oral products 110 canthen be sent to bulk storage and packaged.

In addition to the methods described above, there are many methods formaking and shaping the oral products. In some embodiments, extruded andcut pieces can be introduced into a compression mold to form a finaloral product shape. In other embodiments, the oral product 110 can beinjection molded, compression molded, or injection-compression molded.Blocks of polymer, fiber, and/or additive can also be formed andmachined into a desired shape.

Examples

A series of oral products were produced by extruding a combination ofpolyurethane, cellulosic fiber, nicotine, propylene glycol, sweeteners,and flavorants to produce a variety of oral products, including the oralproducts listed in Table IV below. Each product sample was cut to have athickness of about 3 mm. Each oral product (Products 7, 15, 18, 25, and26) was subjected to the compression @ 250 N test, the compression @ 425N test, and the springiness test discussed above. To compare theproperties of the oral products 110, samples of nicotine replacementtherapy (NRT) chewing gum¹ and a cut piece of a standard eraser² werealso tested. The NRT gum was tested in both its natural state and afterbeing chewed. A chewed sample of Product 25 was also tested. FIG. 9Cdepicts some of the samples. As shown in the chart and in FIGS. 9A and9B, the oral products were less compressive than the chewing gum and theeraser. During the compression tests of the NRT gum, each sample waspunctured by the probe, thus they are indicated as having a 100%compression. The eraser was also punctured by the compression @ 425 Ntest. The oral products, however, each withstood the compression tests.The non-zero values for the compression tests of the oral products,however, indicate that the oral products are pliable and can be workedwithin the mouth. 1 Nicorette Original (2 mg).2 An eraser, also known asa rubber in the UK, is an article of stationery that is used for rubbingout pencil markings.

TABLE IV Sample Com- Com- Thick- pression pression Spring- AnalysisSample ness @ 250N @ 425N iness Date Number Sample ID (mm) (%) (%) (%)Oct. 4, 2011 1 Product 7 3.04 49.65 69.21 86.61 2 Product 15 2.95 60.1783.09 82.10 3 Product 18 3.01 59.44 82.95 83.01 4 Product 25 3.02 61.9284.91 82.27 5 Product 26 3.04 72.10 93.39 81.84 Oct. 11, 2011 6 Product25- 2.88 78.14 95.27 86.32 “chewed” 7 NRT 2.63 100* 100* 15.82 Gum 8 NRT2.72 100* 100* 7.57 Gum- “chewed” 9 Eraser 2.94 87.52 100* 80.82 *Samplewas fully compressed by the probe (resulting in a hole in the sample)

The oral products also demonstrated resilience in the springiness testdiscussed above. As shown, the NRT gum (both chewed and fresh) resultedin very little recovery after compression. The eraser, on the otherhand, demonstrated a similar amount of springiness as compared to theoral products. These tests also demonstrate that the chewed oral productresults in a more compressible product.

A series of oral products were also tested in a mastication test todetermine the additive release profile. The results of this test areshown in FIGS. 10A and 10B. Each sample included polyurethane,cellulosic fiber, peppermint oil, and nicotine. The samples includedabout 2 mg of nicotine and about 1.6% total weight of peppermint oil.One constituent of peppermint oil is menthol. Peppermint oil may containbetween 16 weight percent and 50 weight percent of menthol, usuallyabout 30 weight percent, thus sampling the release of menthol is anappropriate way to approximate the release of peppermint oil. Thedifferent samples included different amounts of polymer (polyurethane),different amounts of cellulosic fiber, or different fiber sizes. Some ofthe samples had 59.70% polyurethane and 33.17% fiber, while othersamples had 67.87% polyurethane and 25.00% fiber. Moreover, some of thesamples had fiber having a size of less than 75 micrometers, some has afiber size of between 75 and 125 micrometers, and some included bulkfiber. The samples also included nicotine and menthol (as a flavorant).Each sample was placed in a mastication tester that manipulated thesample in a solution that mimics saliva. At varying time intervals,samples were taken from the mastication tester to determine the totalamount of menthol and nicotine released. As shown in FIGS. 10A and 10B,each sample continued to have a release of the additives even after 15minutes of mastication. As compared to chewing gums, this is anincreased additive release time period.

The release of menthol was accelerated in the sample having a higherpercentage of polyurethane and a lower percentage of fiber. The releaseof the nicotine was accelerated by having a higher percentage of fiberand by having larger fiber sizes. Accordingly, the release rate ofwater-soluble additives may be determined by the amount of fibers and bythe fiber dimensions in the oral product.

Other Embodiments

It is to be understood that, while the invention has been describedherein in conjunction with a number of different aspects, the foregoingdescription of the various aspects is intended to illustrate and notlimit the scope of the invention, which is defined by the scope of theappended claims. Other aspects, advantages, and modifications are withinthe scope of the following claims.

Disclosed are methods and compositions that can be used for, can be usedin conjunction with, can be used in preparation for, or are products ofthe disclosed methods and compositions. These and other materials aredisclosed herein, and it is understood that combinations, subsets,interactions, groups, etc. of these methods and compositions aredisclosed. That is, while specific reference to each various individualand collective combinations and permutations of these compositions andmethods may not be explicitly disclosed, each is specificallycontemplated and described herein. For example, if a particularcomposition of matter or a particular method is disclosed and discussedand a number of compositions or methods are discussed, each and everycombination and permutation of the compositions and the methods arespecifically contemplated unless specifically indicated to the contrary.Likewise, any subset or combination of these is also specificallycontemplated and disclosed.

What is claimed is:
 1. An oral product, comprising a body that is whollyreceivable in an oral cavity, the body comprising: a fiber-polymermatrix including, a mouth-stable polymer including polyurethane, themouth-stable polymer being present in an amount greater than or equal to60 weight percent, cellulosic fibers embedded in the mouth-stablepolymer, and soluble fibers embedded in the mouth-stable polymer; andnicotine dispersed in the fiber-polymer matrix such that the nicotine isreleased from the body when the body is received within the oral cavityand exposed to saliva, the cellulosic fibers configured to providechannels for the nicotine to be released from the body.
 2. The oralproduct of claim 1, wherein the cellulosic fibers are present in anamount greater than or equal to 10 weight percent.
 3. The oral productof claim 1, further comprising: a plasticizer dispersed in thefiber-polymer matrix, the plasticizer including propylene glycol,glycerin, vegetable oil, triglycerides, or any combination thereof. 4.The oral product of claim 1, further comprising: a sweetener dispersedin the body, the sweetener including saccharine, sucralose, aspartame,acesulfame potassium, or any combination thereof.
 5. The oral product ofclaim 1, further comprising: an additive dispersed in the body, theadditive including minerals, vitamins, dietary supplements,nutraceuticals, energizing agents, soothing agents, amino acids,chemesthetic agents, antioxidants, botanicals, teeth whitening agents,therapeutic agents, or any combination thereof.
 6. The oral product ofclaim 1, further comprising: a flavorant dispersed in the body, theflavorant including licorice, wintergreen, cherry and berry typeflavorants, Drambuie, bourbon, scotch, whiskey, spearmint, peppermint,lavender, cinnamon, cardamom, apium graveolens, clove, cascarilla,nutmeg, sandalwood, bergamot, geranium, honey essence, rose oil,vanilla, lemon oil, orange oil, Japanese mint, cassia, caraway, cognac,jasmine, chamomile, menthol, ylang-ylang, sage, fennel, pimenta, ginger,anise, coriander, coffee, mint oils from a species of the genus Mentha,or any combination thereof.
 7. The oral product of claim 1, furthercomprising: an antioxidant in an amount ranging from 0.01 to 5 weightpercent.
 8. The oral product of claim 1, further comprising: anantioxidant including ascorbyl palmitate, butylated hydroxytoluene(BHT), ascorbic acid, sodium ascorbate, monosterol citrate, atocopherol, propyl gallate, tertiary butylhydroquinone (TBHQ), butylatedhydroxyanisole (BHA), Vitamin E, or any combination thereof.
 9. The oralproduct of claim 1, wherein the nicotine is present in an amount rangingfrom 0.1 mg to 6 mg.
 10. The oral product of claim 1, wherein thecellulosic fibers include sugar beet fiber, wood pulp fiber, cottonfiber, bran fiber, citrus pulp fiber, grass fiber, willow fiber, poplarfiber, or any combination thereof.
 11. The oral product of claim 1,wherein the oral product is substantially free of tobacco plant tissue.12. The oral product of claim 1, wherein the body is shield shaped. 13.The oral product of claim 1, wherein the body has a diameter rangingfrom 5 mm to 25 mm and a thickness ranging from 1 mm to 10 mm.
 14. Anoral product, comprising a body that is wholly receivable in an oralcavity, the body comprising: a porous fiber-polymer matrix including, apolymer including polyurethane, a polyacrylate, polyethylene,poly(styrene-ethylene-butylene-styrene) (SEBS),poly(styrene-butadiene-styrene)(SBS), or any combination thereof, thepolymer being included in an amount greater than or equal to 60 weightpercent, cellulosic fibers embedded in the polymer, and soluble fibersembedded in the polymer; and nicotine, a nicotine derivative, or boththe nicotine and the nicotine derivative disposed in pores of the porousfiber-polymer matrix such that the nicotine, the nicotine derivative, orboth the nicotine and the nicotine derivative is released from the bodywhen the body is received within the oral cavity and exposed to saliva,the cellulosic fibers configured to provide channels for the nicotine,the nicotine derivative, or both the nicotine and the nicotinederivative to be released from the body.
 15. The oral product of claim14, wherein the polymer includes polyurethane.
 16. The oral product ofclaim 14, wherein the cellulosic fibers are present in an amount greaterthan or equal to 10 weight percent.
 17. The oral product of claim 14,wherein the porous fiber-polymer matrix includes a plurality of poreshaving diameters ranging from 20 microns to 60 microns.
 18. The oralproduct of claim 14, wherein the porous fiber-polymer matrix includes afirst plurality of pores having diameters ranging from 40 microns to 60microns, and a second plurality of pores having diameters ranging from 1micron to 10 microns.
 19. The oral product of claim 14, wherein thesoluble fibers include maltodextrin.
 20. An oral product, comprising abody that is wholly receivable in an oral cavity, the body comprising: afiber-polymer matrix including, polyurethane in an amount greater thanor equal to 60 weight percent, cellulosic fibers embedded in thepolyurethane, and soluble fibers embedded in the polyurethane; and anicotine derivative dispersed in the fiber-polymer matrix such that thenicotine derivative is released from the body when the body is receivedwithin the oral cavity and exposed to saliva, the cellulosic fibersconfigured to provide passages for the nicotine derivative to bereleased from the body.
 21. The oral product of claim 20, furthercomprising: a plasticizer dispersed in the fiber-polymer matrix, theplasticizer including propylene glycol, glycerin, vegetable oil,triglycerides, or any combination thereof.
 22. The oral product of claim20, further comprising: a sweetener dispersed in the body, the sweetenerincluding saccharine, sucralose, aspartame, acesulfame potassium, or anycombination thereof.
 23. The oral product of claim 20, furthercomprising: an additive dispersed in the body, the additive includingminerals, vitamins, dietary supplements, nutraceuticals, energizingagents, soothing agents, amino acids, chemesthetic agents, antioxidants,botanicals, teeth whitening agents, therapeutic agents, or anycombination thereof.
 24. The oral product of claim 20, furthercomprising: a flavorant dispersed in the body, the flavorant includinglicorice, wintergreen, cherry and berry type flavorants, Drambuie,bourbon, scotch, whiskey, spearmint, peppermint, lavender, cinnamon,cardamom, apium graveolens, clove, cascarilla, nutmeg, sandalwood,bergamot, geranium, honey essence, rose oil, vanilla, lemon oil, orangeoil, Japanese mint, cassia, caraway, cognac, jasmine, chamomile,menthol, ylang-ylang, sage, fennel, pimenta, ginger, anise, coriander,coffee, mint oils from a species of the genus Mentha, or any combinationthereof.
 25. The oral product of claim 20, further comprising: anantioxidant including ascorbyl palmitate, butylated hydroxytoluene(BHT), ascorbic acid, sodium ascorbate, monosterol citrate, atocopherol, propyl gallate, tertiary butylhydroquinone (TBHQ), butylatedhydroxyanisole (BHA), Vitamin E, or any combination thereof.
 26. Theoral product of claim 20, wherein the cellulosic fibers include sugarbeet fiber, wood pulp fiber, cotton fiber, bran fiber, citrus pulpfiber, grass fiber, willow fiber, poplar fiber, or any combinationthereof.
 27. The oral product of claim 20, wherein the oral product issubstantially free of tobacco plant tissue.
 28. The oral product ofclaim 20, wherein the body is shield shaped.
 29. The oral product ofclaim 1, wherein a ratio of soluble fibers to insoluble fibers rangesfrom 1:60 to 60:1.